EMSA OF THE FUTURE

Quote
Anonymous said:
Harvey is like many others just collecting his salary 275k sal and 125K bonus and doing nothing.
Click to expand...

Hey lets not just pick on Dr. Harvey now, we know that weekly commuting (3 days a week) from Atlanta is hard to do and so his new assignment is to help keep the planet green and lets not forget to help reduce travel costs by showing up to work every other week. Officilally qualifies for a part timer position. I would love that too. Sign me up. The real big winner is that Dr. Richard Murray VP EMSA keeps his current do nothing job and will be allowed to continue his low value scientific leadership or the lack of this agenda. And outcome research area will create tools to publish these findings. So now we know what EMSA of the future will shape up as.
 






ok so they cut payroll expenses, titles, for all their f...ups and the same a..holes continue to hold decision making positions. So really what changes? more spins and lies bundled as the solutions to continue the arrogant self centered focus on a ship without a rudder that is sinking. very difficult to trust anything that these a...holes have to say. honestly doubt if this company can survive with all these dark clouds of doubt with such poor leadership. do any employees trust the emsa or the merck management. for no better name lets call them the idiot squad.
 






Anonymous said:
Like Dick Clark says.... what is lacking is trust factor....with employees, peers, customers....http://www.pharmalot.com/2008/04/mercks-dick-clark-we-have-a-trust-deficit/
Click to expand...

More shame for Merck and its so called "Scientific Leadership" bull........goes to support that all the Merck physicians are linked to the commercial interests at the strategic level of design, ghost writing, holding up studies, turning this material into tactical education with CME, all under the disguise of science and research. So that independent judge was paid $23 mil to say no wrong was committed. Well, come on Dick Clark you are an objective straight talking fellow this is pathetic to see your researcher Dr Jonathan Edelman continue to lie. No way to build trust. I wonder who the 2 top marketing executives were dumb enough (had to be VP level) to nominate these programs for the Merck Marketing Awards. Let me guess in 2004....Adam, Bob, Tom. Now to see these idiots are running the current show has to be beyond scientific logic and not really a confidence building and reassuring regarding the future of the company.

Researchers: Merck Vioxx study was for marketing By LINDA A. JOHNSON, AP Business Writer
1 hour, 20 minutes ago



A 1999 Merck & Co. study of its since-withdrawn painkiller Vioxx, touted to participating doctors and patients as meant to show whether Vioxx caused fewer stomach problems than another drug, was primarily a stealth marketing strategy, researchers report.

The true purpose was to get lots of doctors and patients in the habit of using Vioxx just in time for its launch, according to doctors who uncovered internal Merck memos discussing the strategy behind the study, called ADVANTAGE. They did so while reviewing roughly a million Merck documents for plaintiffs' lawyers preparing for trials in Vioxx lawsuits.

Drug companies are widely suspected of doing many such "seeding," or marketing studies, but there's been no "smoking gun" proving it before, according to the Annals of Internal Medicine, which published Merck's original report on ADVANTAGE in 2003 and will publish the new report Tuesday.

An accompanying editorial, co-authored by Annals editor Dr. Harold C. Sox, states the journal was not told the true purpose of ADVANTAGE, which compared Vioxx with an older, cheaper pain reliever, naproxen, when it published results indicating Vioxx was better tolerated.

Dr. Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, said Monday "the ADVANTAGE study was primarily a scientific study" designed and executed by the company's clinical research unit and that any later use of data for marketing was a separate operation.

But Dr. Kevin P. Hill said he and colleagues, while working as paid consultants for lawyers representing plaintiffs who claimed Vioxx caused heart attacks or other harm, stumbled on documents indicating Merck's marketing division designed ADVANTAGE and handled the data collection and analysis.

Using funding from the Robert Wood Johnson Foundation's clinical scholars program, they searched further, uncovering items such as a memo from two top Merck executives nominating the study for an internal marketing award.

"The objectives were to provide product trial among a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class," the memo states.

ADVANTAGE used about 600 family doctors new to clinical research, with each getting a stipend plus fees for recruiting a handful of patients each. Most clinical trials are run by a limited number of specialists at major teaching hospitals that each recruit hundreds of patients.

Vioxx came on the market in June 1999, after rival Pfizer Inc.'s Celebrex. Both makers claimed their drug caused less cramping, diarrhea and dangerous gastrointestinal bleeding than other pain relievers. Merck battled hard for market share, and Vioxx at its peak brought in about $2.5 billion a year.

Hill, now a staff psychiatrist at McLean Hospital in Massachusetts, said he and his colleagues found documents indicating "ADVANTAGE was marketing framed as scientific research," with an emphasis on how much Vioxx doctors in the study later prescribed.

"I don't think people would be willing to (risk side effects) if they knew that the aim of a clinical trial was to boost profits for a pharmaceutical company," Hill said.

The study's name implied it had a scientific purpose: ADVANTAGE, or Assessment of Differences between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness.

But Hill said doctors participating in ADVANTAGE got a kit telling them how to talk to other doctors about Vioxx, and another Merck study running at the same time, called VIGOR, also examined how safe Vioxx was for people with gastrointestinal problems, so ADVANTAGE wasn't needed. VIGOR's results were published in 2000.

Merck spokesman Ron Rogers said Hill and his colleagues have been critics of Merck and just cherrypicked "some documents to support their thesis."

Dr. Bruce Psaty, a University of Washington epidemiologist, said Hill and his colleagues had disclosed their conflict of interest in their report but that the ADVANTAGE trial wasn't transparent about its purpose.

"I would think that at some level this is standard practice," he said of seeding studies, but they don't come to light except during the discovery phase of litigation.

Dr. Ross McKinney, director of Duke University's bioethics center, said seeding studies have been around for decades and usually are called postmarketing studies, meaning they're for drugs approved for sale. He said most never get published, but this one did because it addressed an important scientific question, stomach tolerability, even though it was a seeding trial. But McKinney said seeding studies make the public skeptical about enrolling in clinical studies.

"It's a serious violation of research ethics" and prevents patients from figuring out the risks and benefits of participating in the study, said Arthur Caplan, who heads University of Pennsylvania's medical ethics department.

Whitehouse Station, N.J.-based Merck pulled Vioxx off the market on Sept. 30, 2004, after its own research showed the then-blockbuster arthritis treatment doubled risk of heart attack and stroke. It has since reached a $4.85 billion settlement to end the bulk of personal injury suits over Vioxx, and the first payment checks are slated to go out later this month.

Sox, the Annals editor, and Dr. Drummond Rennie, the Journal of the American Medical Association's deputy editor, wrote that the institutional review boards required to protect patients in clinical studies should ask whether an experiment is a seeding study, particularly when there are obvious clues.

"Simply shining a bright light on their existence may have already sown the seeds of their destruction," they write.
 






do you mind if i ask the obvious question...

what the hell do you expect when we are first and foremost responsible to our stockholders...

patients come first.....after the street......

by the way, we are no different from any other company operating in a capitalist environment....

not defending just making an observation

we do need to change the slogan....where patients comes first is a really hard sell. maybe we could say "where patients are a close second".
 






Anonymous said:
do you mind if i ask the obvious question...

what the hell do you expect when we are first and foremost responsible to our stockholders...

patients come first.....after the street......

by the way, we are no different from any other company operating in a capitalist environment....

not defending just making an observation

we do need to change the slogan....where patients comes first is a really hard sell. maybe we could say "where patients are a close second".
Click to expand...


HERE HERE. Your slogan is much more apt. Why can't we all just cut through the goddamn bullshit and just say it the way it is? Patients don't come first! Ideally they would, yes, but they don't. It's fucked up.
 






Anonymous said:
do you mind if i ask the obvious question...

what the hell do you expect when we are first and foremost responsible to our stockholders...

patients come first.....after the street......

by the way, we are no different from any other company operating in a capitalist environment....

not defending just making an observation

we do need to change the slogan....where patients comes first is a really hard sell. maybe we could say "where patients are a close second".
Click to expand...

good point...then lets start and accept we are no better than a tobacco company and not confuse the issue by being arrogant and that you are holier than thou. try talking to Adam and Bob they are still delusional about a Merck being number ONE. we have lost out sense of reality and accountiablity. last week business review just more crap about change. what is needed is new management that has a dose of reality, thuth and accountability.
 






Anonymous said:
More shame for Merck and its so called "Scientific Leadership" bull........goes to support that all the Merck physicians are linked to the commercial interests at the strategic level of design, ghost writing, holding up studies, turning this material into tactical education with CME, all under the disguise of science and research. So that independent judge was paid $23 mil to say no wrong was committed. Well, come on Dick Clark you are an objective straight talking fellow this is pathetic to see your researcher Dr Jonathan Edelman continue to lie. No way to build trust. I wonder who the 2 top marketing executives were dumb enough (had to be VP level) to nominate these programs for the Merck Marketing Awards. Let me guess in 2004....Adam, Bob, Tom. Now to see these idiots are running the current show has to be beyond scientific logic and not really a confidence building and reassuring regarding the future of the company.

Researchers: Merck Vioxx study was for marketing By LINDA A. JOHNSON, AP Business Writer
1 hour, 20 minutes ago



A 1999 Merck & Co. study of its since-withdrawn painkiller Vioxx, touted to participating doctors and patients as meant to show whether Vioxx caused fewer stomach problems than another drug, was primarily a stealth marketing strategy, researchers report.

The true purpose was to get lots of doctors and patients in the habit of using Vioxx just in time for its launch, according to doctors who uncovered internal Merck memos discussing the strategy behind the study, called ADVANTAGE. They did so while reviewing roughly a million Merck documents for plaintiffs' lawyers preparing for trials in Vioxx lawsuits.

Drug companies are widely suspected of doing many such "seeding," or marketing studies, but there's been no "smoking gun" proving it before, according to the Annals of Internal Medicine, which published Merck's original report on ADVANTAGE in 2003 and will publish the new report Tuesday.

An accompanying editorial, co-authored by Annals editor Dr. Harold C. Sox, states the journal was not told the true purpose of ADVANTAGE, which compared Vioxx with an older, cheaper pain reliever, naproxen, when it published results indicating Vioxx was better tolerated.

Dr. Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, said Monday "the ADVANTAGE study was primarily a scientific study" designed and executed by the company's clinical research unit and that any later use of data for marketing was a separate operation.

But Dr. Kevin P. Hill said he and colleagues, while working as paid consultants for lawyers representing plaintiffs who claimed Vioxx caused heart attacks or other harm, stumbled on documents indicating Merck's marketing division designed ADVANTAGE and handled the data collection and analysis.

Using funding from the Robert Wood Johnson Foundation's clinical scholars program, they searched further, uncovering items such as a memo from two top Merck executives nominating the study for an internal marketing award.

"The objectives were to provide product trial among a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class," the memo states.

ADVANTAGE used about 600 family doctors new to clinical research, with each getting a stipend plus fees for recruiting a handful of patients each. Most clinical trials are run by a limited number of specialists at major teaching hospitals that each recruit hundreds of patients.

Vioxx came on the market in June 1999, after rival Pfizer Inc.'s Celebrex. Both makers claimed their drug caused less cramping, diarrhea and dangerous gastrointestinal bleeding than other pain relievers. Merck battled hard for market share, and Vioxx at its peak brought in about $2.5 billion a year.

Hill, now a staff psychiatrist at McLean Hospital in Massachusetts, said he and his colleagues found documents indicating "ADVANTAGE was marketing framed as scientific research," with an emphasis on how much Vioxx doctors in the study later prescribed.

"I don't think people would be willing to (risk side effects) if they knew that the aim of a clinical trial was to boost profits for a pharmaceutical company," Hill said.

The study's name implied it had a scientific purpose: ADVANTAGE, or Assessment of Differences between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness.

But Hill said doctors participating in ADVANTAGE got a kit telling them how to talk to other doctors about Vioxx, and another Merck study running at the same time, called VIGOR, also examined how safe Vioxx was for people with gastrointestinal problems, so ADVANTAGE wasn't needed. VIGOR's results were published in 2000.

Merck spokesman Ron Rogers said Hill and his colleagues have been critics of Merck and just cherrypicked "some documents to support their thesis."

Dr. Bruce Psaty, a University of Washington epidemiologist, said Hill and his colleagues had disclosed their conflict of interest in their report but that the ADVANTAGE trial wasn't transparent about its purpose.

"I would think that at some level this is standard practice," he said of seeding studies, but they don't come to light except during the discovery phase of litigation.

Dr. Ross McKinney, director of Duke University's bioethics center, said seeding studies have been around for decades and usually are called postmarketing studies, meaning they're for drugs approved for sale. He said most never get published, but this one did because it addressed an important scientific question, stomach tolerability, even though it was a seeding trial. But McKinney said seeding studies make the public skeptical about enrolling in clinical studies.

"It's a serious violation of research ethics" and prevents patients from figuring out the risks and benefits of participating in the study, said Arthur Caplan, who heads University of Pennsylvania's medical ethics department.

Whitehouse Station, N.J.-based Merck pulled Vioxx off the market on Sept. 30, 2004, after its own research showed the then-blockbuster arthritis treatment doubled risk of heart attack and stroke. It has since reached a $4.85 billion settlement to end the bulk of personal injury suits over Vioxx, and the first payment checks are slated to go out later this month.

Sox, the Annals editor, and Dr. Drummond Rennie, the Journal of the American Medical Association's deputy editor, wrote that the institutional review boards required to protect patients in clinical studies should ask whether an experiment is a seeding study, particularly when there are obvious clues.

"Simply shining a bright light on their existence may have already sown the seeds of their destruction," they write.
Click to expand...

The evidence emerging does not support Dr. Edelman's point of view. This is another example of the research and commercial side trying to spin a story of separation. Keeping it simple, there is no separation it is all about commercialization of a product. The problem is to accept this and build the safeguards to make sure there is no harm to the patient and that the scientific inquiry is legitimate. The lawyers at Merck are doing this spin bullshit to manage their litigation exposure, which is causing the credibility to erode further. Dr. Edelman used to be part of Clinical Development Program which reported to Dr. Louis Sherwood. The CDP department reports to the commercial side since it is involved in conducting late phase 3 and 4 marketing studies. Why else would we enroll 600 physicians?
 






Re: EMSA OF THE FUTUR

here are the facts...

Merck would like to correct numerous inaccuracies in the latest article authored by paid consultants to plaintiffs' lawyers in the VIOXX litigation against Merck and respond to this biased attack on Merck's scientific integrity.1

The scientific purpose of the ADVANTAGE trial was to answer unaddressed questions about VIOXX. The study, a double blind, randomized, controlled trial, was designed, analyzed and published by the Clinical Development (CDP) unit of Merck's US Human Health (USHH) organization, in conjunction with investigators. CDP was part of the Medical and Scientific Affairs department of USHH and was separate from the Marketing department within USHH contrary to the assertion of Hill et al. ADVANTAGE does not meet the definition of a seeding study in any of the references cited by the authors in their paper.2,3

The scientific objectives of the ADVANTAGE study are clearly detailed in the protocol, which was reviewed and approved in February, 1999, through the routine channels including sign off by senior Merck Research Laboratories (MRL) officials.4 These documents were produced to plaintiffs in the VIOXX litigation and available to Hill et al for their analysis and contained keywords from their purported search, despite their assertion that they could find no evidence of MRL involvement in the study. The scientific purpose of ADVANTAGE was properly disclosed to physicians-investigators, participants and institutional review boards and Merck's business interests were understood. The editors of Annals documented in their letter of acceptance for publication of the study in 2003, that physicians would be interested in the type of results ADVANTAGE produced.5

As is always the case, a scientifically sound, rigorously conducted study that shows the benefits of a drug for patients and doctors would also benefit the company that produced the drug. Accordingly, Marketing would be expected to evaluate the commercial possibilities of ADVANTAGE.* This does not change the fact that the primary intent of the study was to answer scientific questions of importance to primary care physicians.

Merck believes there is great value in conducting scientifically based clinical studies to address scientific questions. We believe we acted appropriately in the ADVANTAGE trial, and stand behind our strong beliefs in the principles of scientific integrity. We regret that neither the authors nor editors chose to contact Merck to verify their information or to discuss their conclusions. We encourage readers to read Merck's open letter at: http://www.merck.com/newsroom/press_releases/corporate/. * Note that the correct date of the Marketing memo represented in Figure 1 in the paper by Hill et al. was January 4, 2000, when the study was substantially complete, not 1999.

References: 1. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: a review of internal documents. Ann Intern Med. 2008;149:251-258. 2. Kessler DA, Rose JL, Temple RJ, Schapiro R, Griffin JP. Therapeutic-class wars – drug promotion in a competitive marketplace. N Engl J Med. 1994;331:1350-3. 3. Psaty BAM, Rennie D. Clinical trial investigators and their prescribing patterns: another dimension to the relationship between physician investigators and the pharmaceutical industry [Editorial]. JAMA. 2006;295:2787-90. 4. Carbone KK. ADVANTAGE protocol approval memo. Bates No. LEH804576 to LEH804584. Accessed at http://www.merck.com/newsroom/vioxx/pdf/protocol_approvals.pdf on 19 August 2008. 5. Mulrow CD. ADVANTAGE acceptance letter. Bates No. MRK-APQ0006943 to MRK-APQ0006948. Accessed at http://www.merck.com/newsroom/vioxx/pdf/annals.pdf on 19 August 2008.

Conflict of Interest:

Executive Director, Global Center for
 












Anonymous said:
why all this negative shit. things are bad enough. go take some happy pills. the bad apples are going to get weeded out.
Click to expand...

Agree things are bad and getting worse every day. From a sense of reality, no need for passing out "happy pills" we need something much stronger. You are dealing with an organzation of pathological liars and spin doctors with half truths and we are being called on it. Actually, by a..holes who have a personal vendetta. And guess what they are winning in the court of public opinon. Remember, nothing is wrong with Vioxx the whole world turn on us and that Gilmartin was an idiot. You have heard that. It is so dissappointing to deal with such breakdown of leadership and trust. Guess what, Merck's scientific Koolaide no one is drinking. I worked for this joker Edelman and best I can say go read his HR profile (unless they have purged it) and you will see why this guy has no character to represent Merck in the external scientific area. Big personality disorder. Actually one can make a case and point that he is also a true a..hole. So what he is a Ivy league trained lung doctor from U Penn, trained under Dr. Richard Murray's as a fellow. Senior mangement is a bunch of idiots. How could we select Dr. Edelman of all people to be the poster for your stupid response to the Annals. In 1999 this idiot was Gebba's peer. Plainly said, it is absurb to see what is happening to a once good company. I tell you it is now turned into The Idiot Show of "bad science and horrible management".
 












Anonymous said:
More shame for Merck and its so called "Scientific Leadership" bull........goes to support that all the Merck physicians are linked to the commercial interests at the strategic level of design, ghost writing, holding up studies, turning this material into tactical education with CME, all under the disguise of science and research. So that independent judge was paid $23 mil to say no wrong was committed. Well, come on Dick Clark you are an objective straight talking fellow this is pathetic to see your researcher Dr Jonathan Edelman continue to lie. No way to build trust. I wonder who the 2 top marketing executives were dumb enough (had to be VP level) to nominate these programs for the Merck Marketing Awards. Let me guess in 2004....Adam, Bob, Tom, Charlotte, and others. Now to see these idiots are running the current show has to be beyond scientific logic and not really a confidence building and reassuring regarding the future of the company.

Researchers: Merck Vioxx study was for marketing By LINDA A. JOHNSON, AP Business Writer
1 hour, 20 minutes ago



A 1999 Merck & Co. study of its since-withdrawn painkiller Vioxx, touted to participating doctors and patients as meant to show whether Vioxx caused fewer stomach problems than another drug, was primarily a stealth marketing strategy, researchers report.

The true purpose was to get lots of doctors and patients in the habit of using Vioxx just in time for its launch, according to doctors who uncovered internal Merck memos discussing the strategy behind the study, called ADVANTAGE. They did so while reviewing roughly a million Merck documents for plaintiffs' lawyers preparing for trials in Vioxx lawsuits.

Drug companies are widely suspected of doing many such "seeding," or marketing studies, but there's been no "smoking gun" proving it before, according to the Annals of Internal Medicine, which published Merck's original report on ADVANTAGE in 2003 and will publish the new report Tuesday.

An accompanying editorial, co-authored by Annals editor Dr. Harold C. Sox, states the journal was not told the true purpose of ADVANTAGE, which compared Vioxx with an older, cheaper pain reliever, naproxen, when it published results indicating Vioxx was better tolerated.

Dr. Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, said Monday "the ADVANTAGE study was primarily a scientific study" designed and executed by the company's clinical research unit and that any later use of data for marketing was a separate operation.

But Dr. Kevin P. Hill said he and colleagues, while working as paid consultants for lawyers representing plaintiffs who claimed Vioxx caused heart attacks or other harm, stumbled on documents indicating Merck's marketing division designed ADVANTAGE and handled the data collection and analysis.

Using funding from the Robert Wood Johnson Foundation's clinical scholars program, they searched further, uncovering items such as a memo from two top Merck executives nominating the study for an internal marketing award.

"The objectives were to provide product trial among a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class," the memo states.

ADVANTAGE used about 600 family doctors new to clinical research, with each getting a stipend plus fees for recruiting a handful of patients each. Most clinical trials are run by a limited number of specialists at major teaching hospitals that each recruit hundreds of patients.

Vioxx came on the market in June 1999, after rival Pfizer Inc.'s Celebrex. Both makers claimed their drug caused less cramping, diarrhea and dangerous gastrointestinal bleeding than other pain relievers. Merck battled hard for market share, and Vioxx at its peak brought in about $2.5 billion a year.

Hill, now a staff psychiatrist at McLean Hospital in Massachusetts, said he and his colleagues found documents indicating "ADVANTAGE was marketing framed as scientific research," with an emphasis on how much Vioxx doctors in the study later prescribed.


"I don't think people would be willing to (risk side effects) if they knew that the aim of a clinical trial was to boost profits for a pharmaceutical company," Hill said.

The study's name implied it had a scientific purpose: ADVANTAGE, or Assessment of Differences between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness.

But Hill said doctors participating in ADVANTAGE got a kit telling them how to talk to other doctors about Vioxx, and another Merck study running at the same time, called VIGOR, also examined how safe Vioxx was for people with gastrointestinal problems, so ADVANTAGE wasn't needed. VIGOR's results were published in 2000.

Merck spokesman Ron Rogers said Hill and his colleagues have been critics of Merck and just cherrypicked "some documents to support their thesis."

Dr. Bruce Psaty, a University of Washington epidemiologist, said Hill and his colleagues had disclosed their conflict of interest in their report but that the ADVANTAGE trial wasn't transparent about its purpose.

"I would think that at some level this is standard practice," he said of seeding studies, but they don't come to light except during the discovery phase of litigation.

Dr. Ross McKinney, director of Duke University's bioethics center, said seeding studies have been around for decades and usually are called postmarketing studies, meaning they're for drugs approved for sale. He said most never get published, but this one did because it addressed an important scientific question, stomach tolerability, even though it was a seeding trial. But McKinney said seeding studies make the public skeptical about enrolling in clinical studies.

"It's a serious violation of research ethics" and prevents patients from figuring out the risks and benefits of participating in the study, said Arthur Caplan, who heads University of Pennsylvania's medical ethics department.

Whitehouse Station, N.J.-based Merck pulled Vioxx off the market on Sept. 30, 2004, after its own research showed the then-blockbuster arthritis treatment doubled risk of heart attack and stroke. It has since reached a $4.85 billion settlement to end the bulk of personal injury suits over Vioxx, and the first payment checks are slated to go out later this month.

Sox, the Annals editor, and Dr. Drummond Rennie, the Journal of the American Medical Association's deputy editor, wrote that the institutional review boards required to protect patients in clinical studies should ask whether an experiment is a seeding study, particularly when there are obvious clues.

"Simply shining a bright light on their existence may have already sown the seeds of their destruction," they write.
Click to expand...

Absolutely no credibility and trust will emerge when you are caught lying and you continue to defend your actions. It is ridiculous to see that we are in the business of making science and not marketing bullshit.

Seeding Trials: Taking ADVANTAGE

A case study of a drug trial provides valuable evidence of a disturbing practice: the disguise of marketing schemes as scientific research.

Seeding trials conducted by pharmaceutical companies are clinical studies that are primarily marketing tools but seem designed to answer scientific questions. The existence of such studies has long been suspected, but published information about them has been limited.

An insider’s view of a seeding trial sponsored by Merck & Co. is revealed in a review of confidential internal communications made public because of recent litigation. The ADVANTAGE (Assessment of Differences between Vioxx And Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness) trial was devised by Merck’s marketing division in January 1999, before Vioxx was launched. The stated scientific purpose of the trial was to measure the gastrointestinal safety of rofecoxib. About 2 months before the FDA approved the drug, 600 investigators began randomly assigning 2785 patients with osteoarthritis to receive Vioxx and 2772 to receive naproxen.

A slide set developed by Merck for internal use states that a goal of the study was for investigators to "gain experience with Vioxx prior to and during the critical launch phase." Based on their review of these and other documents, the authors of this case study identified three key themes pertaining to the purposes and development of ADVANTAGE: (1) the trial was designed by Merck’s marketing division for marketing objectives; (2) Merck’s marketing division handled the collection, analysis, and dissemination of both the scientific and the marketing data; and (3) Merck hid the key role of the marketing division and the trial’s marketing objectives from participants, physician-investigators, and institutional review boards. After FDA approval, Merck closely tracked the number of prescriptions that participating physicians wrote for Vioxx and for a competing drug.

Comment: Seeding trials are marketing ruses in the guise of scientific investigations. The apparent purpose of such trials is to test a hypothesis. Their true purpose is to get physicians into the habit of prescribing a new drug. This well-researched and provocative article confirms that deception — of investigators, patients, regulatory bodies, and the public — is a key component of a successful seeding trial. This type of scientific abuse must cease.
 






Why do you think we dealing with the relentless onslaught of stormy SEAs. Reasons to think about:
1. We cannot do any thing wrong....denial syndrome
2. Created an environment of distrust and lies
3. Focused only on the internal issues
4. Change averse
5. Incompetence all all levels
6. Lack of accountability at all levels
7. Bad management decisions
8. No reward for speaking up on the truth
9. No lessons are being learned
10. Breakdown in communications

Probe of Vytorin data widens on Capitol Hill
Friday, September 05, 2008
BY LINDA A. JOHNSON
Associated Press
A House committee investigating the safety and effectiveness of the popular
cholesterol drug Vytorin and one of its components is turning up the heat on
the drug's makers.
The chief executives of Merck and Schering-Plough already were facing a
deadline this week to produce extensive data on a clinical study called SEAS
that indicated a possible cancer risk from Vytorin, which combines Merck's
Zocor, a statin, and Schering-Plough's Zetia, a different type of
cholesterol fighter that is the component under suspicion.
Now the House Energy and Commerce Committee wants answers to more questions
and is asking the companies to let committee staff question the key
statistics expert who has analyzed data on cancer cases and deaths in the
SEAS study and two other ongoing Vytorin studies.
In a letter sent to Merck chief executive Richard T. Clark and
Schering-Plough CEO Fred Hassan this week, the committee directs the
companies to answer questions about the analysis and a report on it by a
highly regarded statistics expert, Sir Richard Peto, co-director of the
Oxford University Clinical Trials Service Unit.
The letter states the committee had expected "a complete assessment of
Vytorin's association with cancer in the SEAS study," but only got a
five-page report, relayed by the Food and Drug Administration on Aug. 21,
that contained little more information than what Peto already had released
publicly.
"We are concerned that an esteemed scientific consultant to Merck and
Schering-Plough may have generated a secret report to FDA," wrote the
committee chair, Rep. John Dingell, and the chair of its Subcommittee on
Oversight and Investigations, Rep. Bart Stupak.
An FDA spokeswoman did not immediately respond to questions about the
allegation. The agency also is investigating whether there's a cancer risk
from Vytorin.
Rosemarie Yancosek, a spokeswoman for Kenilworth-based Schering-Plough, said
the companies know of no other report sent to the FDA and will cooperate
with the committee's latest information request. In an e-mail reply to
questions from the Associated Press, she said the report sent to the FDA was
prepared independently by Peto and university colleagues.
 






It is so depressing to come to work for deceitful individual like Dr. Murray and his band of do/know nothing incompetent jerks. My god it is such a terrible work environment. Keep telling lies about work and make things look better than they seem. How do they do it? I am totally exhausted with all this misinformation, dishonesty and back stabbing. No sense of truth, reality and you know that no one really cares. We are at the point of implosion in EMSA. To postpone the agony until December just prolongs the pain and carnage.
 






I don't think you work in EMSA at all! You are a poseur claiming knowledge of misinformation.

Anyone who trully works in EMSA knows that there has been NO information! Get off this board.
 






Anonymous said:
I don't think you work in EMSA at all! You are a poseur claiming knowledge of misinformation.

Anyone who trully works in EMSA knows that there has been NO information! Get off this board.
Click to expand...

While I get your point (and don't necessarily disagree), misinformation is exactly what our response to this controversy has been.

If it was a trial designed to promote scientific knowledge, then why was the field-based Sales Planning & Support group involved in selecting the A+ Prescribers (and, if memory serves correct, a handful of key A's) involved in the study?

Last I looked, Sales Planning & Support was aligned with Sales & Marketing, not with Clinical Research.

I see absolutely nothing (NOTHING) wrong with doing a seeding trial (smart move, actually .... and it worked wonderfully). I do, however, see very much wrong with the lies that our company, and its public-relation personnel are so easily making now.

Such dishonesty was not a part of the company I joined in the '80s

Too bad.
 






Sir Peto says.....http://www.ctsu.ox.ac.uk/news/ctsu-response

So you have lost trust, credibility, misrepresented science, and forgotten about the patients. Lost the public campaign and left with no capital to trade. Line was crossed with the withholding of Enhance data . The vioxx debacle did not help. You have arrogant idiots running around thinking all is well while the place is in state of disaster.
 






Anonymous said:
Sir Peto says.....http://www.ctsu.ox.ac.uk/news/ctsu-response

So you have lost trust, credibility, misrepresented science, and forgotten about the patients. Lost the public campaign and left with no capital to trade. Line was crossed with the withholding of Enhance data . The vioxx debacle did not help. You have arrogant idiots running around thinking all is well while the place is in state of disaster.
Click to expand...

To sell anything at Merck, you have to bury your soul.
 






Anonymous said:
I don't think you work in EMSA at all! You are a poseur claiming knowledge of misinformation.

Anyone who trully works in EMSA knows that there has been NO information! Get off this board.
Click to expand...

the point is we have no information because no one is working even though they are getting paid. so any late sighting of murray and schuck? out to lunch and next Tuesday ought to be fun to hear dr murray's plan to cut the emsa shop
 












Top Bottom
Back
Quote